Senior NPI Quality & Compliance Leader

PCI Pharma Services

United States

On-site

USD 86,880 - 97,740

Full time

14 days+
Application generator

A complete application in a minute — tailored resume and cover letter, ready to send.

Get past ATS filters

Benefits offered by this job

Health insurance
401(k) plan
Paid time off
Performance bonus

Job summary

PCI Pharma Services is seeking a Quality Manager in the United States to lead a team of Quality Professionals responsible for Design Control activities for NPI projects and ensure quality elements meet new product introduction standards.

The ideal candidate will have a Bachelor's degree in a technical discipline and a minimum of 10 years of experience within relevant industries along with strong management, project oversight, and regulatory compliance knowledge.

This full-time role offers a competitive salary range with benefits, including health insurance and a performance bonus.

Qualifications

  • Minimum of 10+ years of experience in pharmaceutical, biotech, or medical device industries.
  • Expert knowledge of GAMP 5, 21 CFR Parts 820, 210/211, and 11.
  • Full professional proficiency in spoken and written communication.

Responsibilities

  • Lead a team of Quality Professionals for NPI projects.
  • Ensure delivery of quality elements for new product introductions.
  • Make key decisions on product quality and regulatory issues.

Skills

Quality Assurance
Project Management
Regulatory Compliance
Problem Solving
Attention to Detail

Education

Bachelor's degree in engineering, Life Sciences, or related technical discipline

Job description

PCI Pharma Services is seeking a Quality Manager in the United States to lead a team of Quality Professionals responsible for Design Control activities for NPI projects and ensure quality elements meet new product introduction standards.

The ideal candidate will have a Bachelor's degree in a technical discipline and a minimum of 10 years of experience within relevant industries along with strong management, project oversight, and regulatory compliance knowledge.

This full-time role offers a competitive salary range with benefits, including health insurance and a performance bonus.

Get your free, confidential resume review.

or drag and drop your file here.

Similar jobs

Similar jobs worth comparing

NPI Quality Leader – Pharma & Medical Devices
NPI Quality Leader – Pharma & Medical Devices

Pci Pharma Services • Rockford (IL)

On-site
USD 86,000 - 98,000
Health insurance
401(k) plan
Paid time off
+1
Director of Quality & Regulatory Compliance
Director of Quality & Regulatory Compliance

PCI Pharma Services • Bedford (NH)

On-site
USD 150,000 - 210,000
Senior Project Manager, NPI & Regulatory Programs
Senior Project Manager, NPI & Regulatory Programs

qualityconsultinggroup • Juncos (PR)

On-site
USD 90,000 - 130,000
FDA/ISO-Focused Quality Engineering Leader
FDA/ISO-Focused Quality Engineering Leader

Pci Pharma Services • Rockford (IL)

On-site
USD 108,000 - 137,000
401(k) plan
Health insurance coverage
Paid time off
+1
Quality Manager, NPI
Quality Manager, NPI

Pci Pharma Services • Rockford (IL)

On-site
USD 86,000 - 98,000
Health insurance
401(k) plan
Paid time off
+1
Manager, Compliance
Manager, Compliance

pciservices • San Diego (CA)

On-site
USD 107,000 - 120,000
Quality Manager, NPI
Quality Manager, NPI

PCI Pharma Services • United States

On-site
USD 86,880 - 97,740
Health insurance
401(k) plan
Paid time off
+1
Senior Director, QC Strategy & Global Operations
Senior Director, QC Strategy & Global Operations

PCI Pharma Services • Bedford (NH)

On-site
USD 190,000 - 270,000
Senior Director, Global QC Strategy & Lab Excellence
Senior Director, Global QC Strategy & Lab Excellence

PCI TRGR Penn Pharmaceutical Services Ltd • Bedford (NH)

Hybrid
USD 180,000 - 250,000
Director of QA & Regulatory Compliance
Director of QA & Regulatory Compliance

PCI Pharma Services • Tennessee

On-site
USD 110,000 - 170,000